An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease

• ClinicalTrials.gov Identifier: NCT00002166
• Recruitment Status: Completed
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Sponsor: Boehringer Ingelheim
• Information provided by: NIH AIDS Clinical Trials Information Service

Study Description

Brief Summary:

To provide access to Viramune and to evaluate the tolerance and safety of Viramune in patients with progressive, symptomatic HIV disease who failed or are intolerant to currently approved treatment for HIV-1 infection and who are unable to participate in another Viramune controlled clinical trial and have a compelling need for anti-HIV treatment.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Nevirapine	Phase 3

Detailed Description:

Eligible adult patients (>= 13 years of age) will receive treatment with Viramune once daily for 2 weeks and then twice daily. Eligible pediatric patients (< 13 years of age) will receive a lower dose of Viramune once daily for 2 weeks and then twice daily. All patients will receive Viramune with or without concomitant antiretroviral therapy. Patients will be evaluated at weeks 2, 4, 8, 16, 24, 32 and every 8 weeks thereafter.

PER AMENDMENT 01/31/97: Enrollment closed to adult patients. As of 1/31/97 only enrolling pediatric patients.

Study Design

• Study Type: Interventional (Clinical Trial)
• Intervention Model: Parallel Assignment
• Primary Purpose: Treatment
• Official Title: An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 1 Day and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria

Patients must have:

• Patients > 18 months of age with history of positive serology for HIV-1 infection or patients <= 18 months of age with history of positive viral culture, detectable p24 antigen, or positive peripheral blood mononuclear cell macro culture.
• Patients >= 13 years of age with a CD4+ cell count <= 200 cells/mm3. Patients < 13 years of age with a CD4% <= 14% or a 50% decrease in CD4% in the past 6 months if the previous CD4% was >=20%.
• Patient has failed or is intolerant to currently approved treatments for HIV-1 infection and is unable to participate in a controlled viramune clinical trial.
• Written and informed consent from a parent or guardian for patients < 18 years of age.
• Patient or guardian is willing and able to follow protocol requirements. (PER AMENDMENT 1/29/97:
• Enrollment is closed to adults, as of Jan. 29th only pediatric patients will be enrolled.)

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

Patient qualifies for participation in an actively accruing Viramune controlled clinical trial.

Concurrent Medication:

Excluded:

• Dicumarol, Warfarin, and other anticoagulant medications.
• Tolbutamide.
• Investigational drugs, all protease inhibitors, and all other non-nucleoside transcriptase inhibitors.
• Neurotoxic drugs.
• Cimetidine.
• Erythromycin.

Required:

Patient has failed or is intolerant to currently approved treatments for HIV-1 infection.

Contacts and Locations

Locations

United States, Connecticut

Boehringer Ingelheim Pharmaceuticals Inc

Ridgefield, Connecticut, United States, 06877

Sponsors and Collaborators

Boehringer Ingelheim

More Information

• ClinicalTrials.gov Identifier: NCT00002166
• Other Study ID Numbers: 200D; 1100.859
• First Posted: August 31, 2001
• Last Update Posted: June 24, 2005
• Last Verified: August 2002

Keywords provided by NIH AIDS Clinical Trials Information Service:

Nevirapine; Reverse Transcriptase Inhibitors; Anti-HIV Agents

Additional relevant MeSH terms:

HIV Infections; Acquired Immunodeficiency Syndrome; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Nevirapine; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents; Anti-HIV Agents; Anti-Retroviral Agents; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 Enzyme Inducers